BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 2222977 · Received August 10, 2011

    Report

    Report Number
    3004608878-2011-00112
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 12, 2011
    Report Date
    August 10, 2011
    Manufacturer
    INTEGRA, CINCINNATI
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE REPORTED INFORMATION AND EVALUATION OF THE RETURNED PRODUCT, THE FINDINGS WERE AS FOLLOWS: WHEN THE CLAMP WAS PUT UNDER PRESSURE, THE REPORTED INCIDENT OF SLIPPAGE COULD NOT BE DUPLICATED. THE 80 POUND TORQUE KNOB TESTED GOOD UNDER PRESSURE. THE RATCHET EXTENSION ARM HAD NO VISIBLE CRACKS. THE LOCK HAD A LITTLE ROTATIONAL MOVEMENT AND BUT THIS WOULD NOT HAVE CAUSED THE SLIPPAGE. THE LARGE STARBURST TEETH SHOWED SOME WEAR BUT WERE STILL FUNCTIONAL AND THIS WOULD NOT HAVE CAUSED THE SLIPPAGE. THE ROCKER ARM PASSED THE GO NOGO GAGE. ALL OTHER COMPONENTS WERE FUNCTIONAL. GENERAL MAINTENANCE AND CLEANING WERE REQUIRED. INTEGRA CONSIDERS THIS COMPLAINT INVESTIGATION CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED ON (B)(6) 2011 THAT THE MAYFIELD MODIFIED SKULL CLAMP SLIPPED FROM LEFT TO RIGHT WHILE ON THE PATIENT'S HEAD. SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY. ON (B)(6) 2011, ADDITIONAL INFORMATION WAS RECEIVED THAT THE CLAMP MOVED EVEN WITH THE 80 POUNDS OF PRESSURE AND THE TIGHTENING HANDLE HAVING THE NECESSARY PRESSURE. THE TWO PARTS OF THE CLAMP WIGGLED MORE THAN USUAL. NO PROBLEMS/DAMAGE WERE EXPERIENCED ON THE PATIENT. THERE WAS "NO SLIPS." THE LENGTH OF TIME THE CLAMP WAS IN USE BEFORE THE EVENT OCCURRED WAS ABOUT FOUR HOURS. NO STEROTAXY DEVICE WAS USED. THE PATIENT WAS INITIALLY POSITIONED PRONE AND WAS NO REPOSITIONED DURING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA, CINCINNATI 101

    Patients

    Seq Age Sex Outcome Treatment
    1